Itrax

Package Leaflet: Information for the Patient

Itrax, 100 mg, Hard Capsules

Itraconazole

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medication has been prescribed specifically for you. Do not pass it on to others. The medication may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including those not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Leaflet

• 1. What is Itrax and what is it used for
• 2. Important information before taking Itrax
• 3. How to take Itrax
• 4. Possible side effects
• 5. How to store Itrax
• 6. Package contents and other information

1. What is Itrax and what is it used for

Itrax contains the active substance itraconazole, which belongs to the group of thiazole derivatives and is a broad-spectrum antifungal agent.
Itrax is indicated for the treatment of:

• genital infections: vaginal thrush and vulvovaginal thrush;
• skin, mucous membrane, or eye infections: skin thrush, pityriasis versicolor, oral thrush, fungal keratitis;
• fungal nail infections caused by dermatophytes and/or yeasts;
• systemic fungal infections (fungal infections of various organs and tissues): systemic aspergillosis and systemic candidiasis, cryptococcosis, including cryptococcal meningitis, in patients with cryptococcosis and impaired immunity, and in all patients with cryptococcal central nervous system infection (Itrax is indicated only when first-line treatment is ineffective), histoplasmosis, blastomycosis, sporotrichosis, paracoccidioidomycosis, and other rare systemic or tropical fungal infections.

2. Important information before taking Itrax

When not to take Itrax

• If the patient is allergic to the active substance or any of the other ingredients of this medication (listed in section 6).
• If the patient has or has had heart problems, such as congestive heart failure, unless it is a life-threatening infection or other severe infection. Symptoms of congestive heart failure include: shortness of breath, unexpected weight gain, swelling of the limbs or abdomen, severe fatigue, or waking up at night with shortness of breath.

Do not take Itrax if you are pregnant (except in life-threatening situations). Women of childbearing age taking Itrax should use effective birth control methods until the first menstrual period after stopping Itrax.

• If the patient is taking certain other medications, see "Itrax and other medications".

Warnings and precautions

If the patient has any of the following conditions, they should discuss it with their doctor or pharmacist beforetaking Itrax.

• The patient has kidney problems. A dose adjustment may be necessary.
• The patient has liver problems. A dose adjustment may be necessary. The doctor may recommend monitoring liver function in patients taking Itrax, as it can rarely cause severe liver damage.
• The patient has heart problems.
• The patient has had an allergic reaction to another antifungal medication.
• The patient has impaired immunity, e.g., due to neutropenia, AIDS, or organ transplantation. A dose adjustment may be necessary.
• The patient is taking other medications.

If the patient experiences any of the following symptoms while taking Itrax, they should inform their doctor.

• Symptoms of liver inflammation: loss of appetite, nausea, vomiting, fatigue, abdominal pain, yellowing of the skin or eyes, pale stools, or dark urine - stop taking Itrax and consult a doctor immediately.
• Symptoms of congestive heart failure: shortness of breath, unexpected weight gain, swelling of the legs, unusual fatigue, or waking up at night with shortness of breath - stop taking Itrax and consult a doctor immediately.
• Symptoms of a severe allergic reaction: rash, itching, hives, difficulty breathing, or swelling of the face - stop taking Itrax and consult a doctor immediately.
• Increased sensitivity to light.
• Severe skin reactions, such as generalized rash with skin peeling and blisters in the mouth, eyes, and genital areas, or rash with small blisters or vesicles - stop taking Itrax and consult a doctor immediately.
• Symptoms of neuropathy (nerve damage), such as: tingling, numbness, decreased sensation, weakness, headache, dizziness - stop taking Itrax and consult a doctor immediately.
• Symptoms of hearing loss.
• Blurred or double vision, ringing in the ears, incontinence, or frequent urination.

Itrax and other medications

Tell your doctor about all medications you are currently taking or have recently taken, as well as any medications you plan to take.
Medications that should not be taken with Itrax:

• certain allergy medications: terfenadine, astemizole, mizolastine;
• certain medications for angina pectoris (coronary artery disease) or high blood pressure: bepridil, felodipine, nizoldipine, lerkanidipine, ivabradine, ranolazine, eplerenone;
• ticagrelor - a medication that reduces blood clotting;
• cisapride - a medication used for gastrointestinal motility disorders;
• certain cholesterol-lowering medications: simvastatin, lovastatin;
• certain sleep aids: midazolam (oral), triazolam;
• certain medications for psychotic disorders: lurasidone, pimozide, sertindole;
• certain medications for severe pain or addiction: levacetylmethadol (also known as levo-methadyl), methadone;
• halofantrine - a medication used for malaria;
• irinotecan - an anticancer medication;
• ergot alkaloids used for migraine headaches: dihydroergotamine or ergotamine;
• ergot alkaloids used to control bleeding and maintain uterine contractions after childbirth: ergometrine (also known as ergonovine) or methylergometrine (also known as methylergonovine);
• certain medications for arrhythmias: disopyramide, dronedarone, quinidine, dofetilide;
• domperidone - a medication used for nausea and vomiting;
• telithromycin in patients with severe kidney or liver impairment;
• fezoterodine in patients with moderate or severe kidney or liver impairment;
• solifenacin in patients with severe kidney or liver impairment;
• colchicine in patients with kidney or liver impairment.

If you are taking any of these medications, do not take Itrax.
If you are taking Itrax, do not start taking these medications until at least 2 weeks after stopping Itrax.
Medications that may reduce the effectiveness of Itrax:

• antiepileptic medications: carbamazepine, phenytoin, phenobarbital;
• antituberculosis medications: rifampicin, rifabutin, isoniazid;
• HIV/AIDS medications: efavirenz, nevirapine. If you are taking any of these medications, always inform your doctor.

Medications that should not be taken with Itrax, unless the doctor considers it necessary:

• certain anticancer medications: axitinib, dabrafenib, dasatinib, ibrutinib, nilotinib, sunitinib, trabectedin;
• aliskiren - a medication used for high blood pressure;
• sildenafil, when used for pulmonary hypertension;
• rifabutin - an antituberculosis medication;
• carbamazepine - an antiepileptic medication;
• colchicine - a medication used for gout;
• conivaptan, tolvaptan - medications used for low sodium levels in the blood;
• darifenacin - a medication used for urinary incontinence;
• everolimus - a medication used after organ transplantation;
• fentanyl - a strong pain medication;
• apixaban, rivaroxaban - medications that reduce blood clotting;
• salmeterol - a medication used for asthma;
• simeprevir - a medication used for hepatitis C;
• tamsulosin - a medication used for urinary incontinence in men;
• vardenafil - a medication used for erectile dysfunction. These medications can be started 2 weeks after stopping Itrax.

Other medications that interact with Itrax:

• certain antibiotics: ciprofloxacin, clarithromycin, erythromycin, telithromycin;
• certain heart or blood vessel medications: bosentan, digoxin, nadolol, riociguat, and certain calcium channel blockers, including verapamil;
• blood thinners: coumarins, cilostazol, dabigatran;
• methylprednisolone, budesonide, ciclesonide, fluticasone, or dexamethasone - taken orally, by injection, or inhaled for the treatment of inflammatory conditions, asthma, and allergies;
• cyclosporine, tacrolimus, temsirolimus, sirolimus (also known as rapamycin) - usually taken after organ transplantation;
• certain HIV/AIDS medications (AIDS): maraviroc, protease inhibitors, including indinavir, ritonavir, darunavir, fosamprenavir, saquinavir;
• certain anticancer medications: bortezomib, busulfan, docetaxel, erlotinib, gefitinib, imatinib, ixabepilone, lapatinib, ponatinib, trimetrexate, vinca alkaloids;
• certain medications for anxiety or sleep: buspirone, perospirone, ramelteon, midazolam (given intravenously), alprazolam, brotizolam;
• certain strong pain medications: alfentanil, buprenorphine, oxycodone, sufentanil;
• certain medications for diabetes: repaglinide, saxagliptin;
• certain medications for psychosis: aripiprazole, haloperidol, quetiapine, risperidone;
• certain medications for nausea and vomiting: aprepitant;
• certain medications for urinary tract infections: fezoterodine, imidafenacin, oxybutynin, solifenacin, tolterodine;
• certain medications for erectile dysfunction: sildenafil, tadalafil;
• praziquantel - an antiparasitic medication;
• bilastine, ebastine - antihistamines;
• reboxetine - an antidepressant;
• atorvastatin - a cholesterol-lowering medication;
• meloxicam - a medication used for arthritis and pain;
• cinacalcet - a medication used for hyperparathyroidism;
• certain medications for low sodium levels in the blood: mozavaptan;
• alitretinoin (taken orally) - a medication used for eczema;
• eletriptan - a medication used for migraine headaches. If you are taking any of these medications, your doctor may need to adjust the dose of these medications or Itrax.

Medications that affect itraconazole absorption

• Medications that reduce stomach acid should be taken at least 1 hour before or at least 2 hours after taking Itrax, as they can interfere with itraconazole absorption from Itrax capsules.
• If you are taking medications that reduce stomach acid secretion, take Itrax with acidic beverages (e.g., cola). This is because these medications can interfere with itraconazole absorption from Itrax capsules.

In case of doubts, consult a doctor or pharmacist.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult a doctor or pharmacist before taking this medication.
Itrax should not be taken during pregnancy, except in life-threatening situations where the potential benefits of treatment outweigh the potential risks to the fetus.
Women of childbearing age taking Itrax should use effective birth control methods until the first menstrual period after stopping Itrax.
Itraconazole is excreted in small amounts into breast milk. The doctor will decide whether the expected benefits of Itrax outweigh the risks to the baby. In case of doubts, the patient should not breastfeed.

Driving and using machines

Itrax may cause dizziness, blurred or double vision, or hearing loss.
If you experience these symptoms, do not drive or operate machinery.

Itrax contains sucrose

One Itrax capsule contains 216.6 mg of sucrose.
If you have been diagnosed with intolerance to some sugars, consult a doctor before taking Itrax.

3. How to take Itrax

Take this medication exactly as your doctor has told you. If you are unsure, consult a doctor or pharmacist.

Take Itrax immediately after a full meal. Swallow the capsules whole.
Dosage for adults

Elimination of itraconazole from the skin and nails occurs more slowly than from the blood. Optimal treatment results in terms of clinical symptoms and microbiological results are achieved within 2 to 4 weeks after the end of treatment for skin infections and within 6 to 9 months after the end of treatment for nail infections.

The doctor will adjust the duration of treatment according to the patient's response to treatment.

Use in children

Itrax can be used in children only if the doctor decides that the expected benefits outweigh the potential risks.

Overdose

In case of overdose, consult a doctor immediately.

Missed dose

Do not take a double dose to make up for a missed dose.

Stopping treatment

Continue taking Itrax for as long as your doctor recommends. Do not stop treatment on your own, even if you feel better.
In case of any further doubts about taking this medication, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medications, Itrax can cause side effects, although not everybody gets them.
In clinical trials involving 8499 patients taking itraconazole, the following side effects occurred in at least 1 in 100 patients: headache, nausea, and abdominal pain.
In these clinical trials, the following side effects occurred in less than 1 in 100 patients taking itraconazole: nasal congestion, sinusitis, upper respiratory tract infections, low white blood cell count, hypersensitivity, taste disorders, numbness, paresthesia (tingling, numbness, decreased sensation), tinnitus, constipation, diarrhea, indigestion, bloating, vomiting, abnormal liver function, high bilirubin levels in the blood, itching, rash, hives, frequent urination, erectile dysfunction, menstrual disorders, and swelling.

The following side effects have been reported after the marketing of itraconazole in relation to all its pharmaceutical forms:

• Very rare side effects(may occur in less than 1 in 10,000 patients):
• serum sickness-like reaction (a type of systemic allergic reaction), angioedema (swelling that occurs most commonly in the face or throat and can make breathing difficult), anaphylactic reaction (allergic reaction);
• tremors;
• hypertriglyceridemia (high levels of triglycerides in the blood);
• visual disturbances (including double and blurred vision);
• transient or permanent hearing loss;
• congestive heart failure (including symptoms such as shortness of breath, unexpected weight gain, swelling of the limbs or abdomen, severe fatigue, or waking up at night with shortness of breath);
• shortness of breath;
• pancreatitis;
• severe hepatotoxicity (severe liver damage, including several cases of death due to acute liver failure);
• severe, exfoliative skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme, exfoliative dermatitis), acute generalized exanthematous pustulosis, leukocytoclastic vasculitis (inflammation of small blood vessels in the skin), alopecia, increased sensitivity to light;
• increased creatine phosphokinase activity in the blood.

Additional side effects in children and adolescents

In clinical trials involving children and adolescents (aged 1 to 17 years) taking itraconazole, the following side effects occurred in more than 1 in 100 patients: headache, vomiting, abdominal pain, diarrhea, liver function disorders, hypotension, nausea, and hives.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Jerozolimskie Avenue 181C, 02-222 Warsaw, phone: 22 49-21-301, fax: 22 49-21-309, e-mail: [email protected]
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medication.

5. How to store Itrax

Keep the medication out of sight and reach of children.
Store in a temperature below 25°C, protected from light.
Do not use this medication after the expiration date stated on the outer packaging and blister pack after "EXP". The expiration date refers to the last day of the month stated.
Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Itrax contains

• The active substance of Itrax is itraconazole. One capsule contains 100 mg of itraconazole.
• Other ingredients are: hypromellose, eudragit E-100, sucrose, macrogol 20000; capsule shell:titanium dioxide (E 171), gelatin.

What Itrax looks like and contents of the pack

Itrax is a white capsule.
The packaging contains blisters packed in cardboard boxes, containing 4 or 28 capsules.

Marketing authorization holder

Aristo Pharma Sp. z o.o.
Baletowa Street 30
02-867 Warsaw

Manufacturer

Olpha AS
5 Rupnicu Street
Olaine LV-2114
Latvia
Date of last revision of the leaflet:February 2025